Trial document
DRKS00017687
Trial Description
Title
Music-assisted treadmill training in the therapy of Parkinson's disease
Trial Acronym
MATT study
URL of the Trial
[---]*
Brief Summary in Lay Language
[---]*
Brief Summary in Scientific Language
Parkinson’s Disease (PD) is one of the main neurodegenerative disease in Germany and in western industry nations with increasing number of patients due to the demographic change. In the course of the disease PD patients suffer from motor and non-motor symptoms. Only a limited number of pharmacotherapies for the symptomatic treatment of PD patients are available and so is the invasive deep brain stimulation (DBS), which is limited to a selected group of patients. Inducing an urgent need for alternative, non-pharmacologic therapy options.
Motor and cognitive therapies are established treatments, however in the usual care routines they are applied independent (if at all) from on another even though a growing understanding of motor function and cognition as linked entities exists. Furthermore patient’s motivation for long-term adherence can be a challenge in progressive disease.
Treadmill training and cueing are successfully applied in routine care of PD patients to improve gait. Patients consider the training with musically auditive cues as especially motivating. A music assisted gait training showed better effects than a usual treadmill training. However, these studies mainly focused on motor functional outcomes, so that a remaining research interest exists to examine the possible effects on cognition. Furthermore, studies rarely include patient-centered outcomes, so that the current project aims at evaluation these. Additionally there is little evidence about the mid-term effects of a music-assisted treadmill training so that these will be evaluated as well.
In the current pilot-project with a randomized controlled design and follow-up telephone interview after six weeks, we aim at the evaluation of feasibility as well as short- and mid-term effects of a music-assisted treadmill training on cognition. Furthermore the patient-centered outcomes of mood, motivation, fatigue, and fun will be compared to an usual ergometer training.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00017687
- 2019/09/25
- [---]*
- yes
- Approved
- 19-1291, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
- U1111-1240-9458
Health Condition or Problem studied
- G20 - Parkinson disease
Interventions/Observational Groups
- 20 min music assisted treadmill training plus regular motor and cognitive rehabilitation therapy for 8 training days
- 20 min ergometertraining plus regular motor and cognitive rehabilitation therapy for 8 training days
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
Cognition
- Overall cognition (MoCA)
- Alertness (TAP)
- selective Attention (TAP)
- reaction time (WTS, RT-S5)
- Inhibition (TAP)
- cognitive flexibility (TAP; TMT B/A)
- word fluency (RWT)
- short-term memory (number and Digit span of WMS-R; visual reproduction of WMS-R)
- working memory (number and Digit span of WMS-R)
- mentale rotation (LPS-2, Subtest 7)
- visual scanning (TAP, TMT- A)
- learning strateges (CVLT; TOL-D)
Secondary Outcome
Motor Function
- gros motor function: Fist Closure Frequency
- fine motor function: NHPT
- Balance/ risk for falls: BBS; TUG; TUG+DT
- gait: 10mGT
- Freezing: FoGQ
- functional independence: FIM
Ability to sychronize
Motivation, mood, fatigue und fun while training
Disease severity (H&Y; UPDRS)
Depression (GDS)
Quality of life (PDQ-39; EQ-5D)
Activity level (IPAQ)
Fatigue (PFS- 16)
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2019/09/26
- 70
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 110 Years
Additional Inclusion Criteria
- Patients with Parkinson's disease
- no further neurological or psychiatric disease, that interferes with study participation
- no hint at a medium severe depression(cut-off: < 10 Points on Geriatric Depression Scale)
- no other disease (cardiologic or orthpedic), that interferes with study participation
- undisturbed or sufficiently corrected vision and hearing
- Participant speaks German
- Patient can provide informed consent (cut-off: Montreal Cognitive Assessment (MoCA) > 17 points; Freitas et al., 2014)
- Patient can follow therapeutic instructions
- Patient provides written consent for study participation
- scheduled stay of at least 14 days at neurological rehabilitations center Godeshöhe e.V.
Exclusion Criteria
- severe disturbtion of vigilance, of speech or psychiatric, which interfere with understanding of study aims and/ or instructions, and decrease safety during
- daily uncontrolled changes in medication or Stimulation Settings, which would decrease safety
Addresses
-
start of 1:1-Block address primary-sponsor
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
- Ms. Prof. Dr. rer. nat. Elke Kalbe
- Kerpenerstr. 62
- 50937 Köln
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 221 478-6669
- +49 221 478-3420
- elke.kalbe at uk-koeln.de
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Neurologisches Rehabilitationszentrum Godeshöhe e. V.
- Mr. Diplom Psychologe Jochen Saliger
- Waldstr. 2-10
- 53177 Bonn
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +49 228 381 – 703 (Sekretariat)
- +49 228 381 - 318
- j.saliger at godeshoehe.de
- http://www.godeshoehe.de
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
- Ms. Prof. Dr. rer. nat. Elke Kalbe
- Kerpenerstr. 62
- 50937 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 221 478-6669
- +49 221 478-3420
- elke.kalbe at uk-koeln.de
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
- Ms. MSc Mareike Gooßes
- Kerpenerstr. 62
- 50937 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 221 478-96250
- +49 221 478-3420
- mareike.goosses at uk-koeln.de
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie.
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Medizinische Psychologie | Neuropsychologie und Gender Studies und Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
- Ms. Prof. Dr. med Elke Kalbe
- Kerpener Str. 62
- 50937 Köln
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 221 478-6669
- +49 221 478-3420
- elke.kalbe at uk-koeln.de
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
- [---]*
- [---]*
- [---]*
- [---]*
Trial Publications, Results and other Documents
- [---]*